Social Cognition and Personality Changes in Alzheimer's & Parkinson's Disease & Frontotemporal Lobar Degeneration

Parkinson's Disease Clinical Trial

Official title:

Assessing Changes in Social Cognition and Personality in Patients With Frontotemporal Lobar Degeneration, Alzheimer's Disease and Parkinson's Disease and Their Effect on the Patient-caregiver Relationship

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964611
• Other study ID #: 12-0451-BE
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: University Health Network, Toronto
• Contact: Cristina Salvo, BSc, MD
• Phone: 416-507-6880
• Email: cristina.salvo[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to compare personality and social cognition changes, including emotion detection and self-awareness, and neuroanatomical correlates in patients, and how that affects the caregiver-patient relationship.

Description:

The purpose of this study is to understand social cognition changes in patients with Alzheimer's disease (AD), Parkinson's disease (PD), and Frontotemporal Lobar Degeneration (FTLD), which includes Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS) and Frontotemporal Dementia (FTD - behavioural variant frontotemporal dementia, progressive non-fluent aphasia and semantic dementia), and the effect of these changes on the patients' relationship with their caregivers. In addition, the study aims to provide a greater clarity in the neuroanatomical correlates of social cognition in patients with FTLD, PD and AD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

Patients:

• ability to speak and understand the English language (as questionnaires and tests are only available in English)

Caregivers:

• primary caregiver for a given patient

• ability to speak and understand the English language (as questionnaires and tests are only available in English)

Exclusion Criteria:

Patients and Caregivers:

• history of another neurological disorder

• psychiatric disorder

• severe aphasia (semantic word loss)

• visual deficits requiring correction beyond the use of eyeglasses or contact lenses (intact visual acuity is required for completing both the questionnaires and the emotion evaluation test which consists of video vignettes)

• auditory deficits requiring correction beyond hearing aids (videos have auditory component)

Patients:

• presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body will be excluded as they will be unable to have a MRI scan.

• premenopausal women will be excluded due to the unknown risk of MRIs during pregnancy.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Frontotemporal Lobar Degeneration
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Observational Study
This is an observational study.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD	Assesses interpersonal aspects of personality	one time visit, through study completion of 3 years
Primary	Personality via the Behaviour Inhibition/Approach Scale (BIS/BAS) and differences between AD, PD, and FTLD	Assesses the behavioural approach system that regulates appetitive motives, in which the goal is to move toward something desired, and the behavioural avoidance (or inhibition) system that regulates aversive motives, in which the goal is to move away from something unpleasant	one time visit, through study completion of 3 years
Primary	Personality via the Big Five Inventory (BFI) and differences between AD, PD, and FTLD	Assesses the patient's Big Five dimensions (openness, conscientiousness, extraversion, agreeableness, and neuroticism) with respect to past and current behavior	one time visit, through study completion of 3 years
Primary	Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD	Assesses the patient's understanding of culturally relevant social norms	one time visit, through study completion of 3 years
Primary	Social cognition via Interpersonal Reactivity Index (IRI) and differences between AD, PD, and FTLD	Assesses the patient's empathy or ability to share in another's mental and emotional experience	one time visit, through study completion of 3 years
Primary	Social cognition via Revised Self-Monitoring Scale (RSMS) and differences between AD, PD, and FTLD	Assesses the patient's sensitivity to the expressive behaviour of others and their ability to monitor their self-presentation	one time visit, through study completion of 3 years
Primary	Social cognition via Social Behaviour Observer Checklist and differences between AD, PD, and FTLD	Assesses behaviors specific to behavioural variant Frontotemporal Dementia (bvFTD) and is helpful in differentiating bvFTD versus Alzheimer's disease.	one time visit, through study completion of 3 years
Primary	Neuropsychiatric Inventory (NPI) and differences between AD, PD, and FTLD	Assesses 12 neuropsychiatric disturbances commonly encountered in patients with dementia, including: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behaviour, night-time behaviour disturbances, and appetite and eating abnormalities	one time visit, through study completion of 3 years
Primary	Clinical Dementia Rating Scale (CDR) and differences between AD, PD, and FTLD	Assesses 8 domains of global dementia, including: memory, orientation, judgment/problem solving, community affairs, home and hobbies, personal care, behavioural comportment and personality, and language	one time visit, through study completion of 3 years
Primary	Functional Activities Questionnaire (FAQ) and differences between AD, PD, and FTLD	Assesses functional capacity in older adults	one time visit, through study completion of 3 years
Primary	Behavioural Tests composite score and differences between AD, PD, and FTLD	Orientation, Digit span backward and forward, Naming, Modified trails, Benson figure copy, Cerad, Clock draw	one time visit, through study completion of 3 years
Primary	Emotion Evaluation Task (EET) portion of The Awareness of Social Inference Test and differences between AD, PD, and FTLD	Assesses the recognition of six basic emotions commonly recognized across cultures (happiness, sadness, anger, surprise, disgust, fear) as well as a seventh "neutral" emotion. The emotions are presented via video vignettes. After viewing each scene, the patient will be asked to choose the emotion represented from a list of seven emotional categories. The caregiver will complete the test separately, and be asked both to guess the emotion in each vignette, and to speculate on which emotion the patient will guess.	one time visit, through study completion of 3 years
Primary	Geriatric Depression Scale (GDS) and differences between AD, PD, and FTLD	Assesses mood and depression in geriatric patients	one time visit, through study completion of 3 years
Primary	Neuroimaging and differences between AD, PD, and FTLD	Functional connectivity of networks associated with social cognition and personality	one time visit, through study completion of 3 years